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NCT01676519 Clinical Trial

Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

Critical Limb Ischemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01676519
Other study ID # Arezzo007
Secondary ID
Status Completed
Phase N/A
First received August 23, 2012
Last updated August 30, 2012
Start date July 2002
Est. completion date December 2011

Study information
Verified date August 2012
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.

Recruitment information / eligibility
Status Completed
Enrollment 764
Est. completion date December 2011
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diabetes mellitus

- need for coronary revascularization

- age > 18 years

Exclusion Criteria:

- clinical contraindications to prolonged double antiplatelet therapy

- life expectancy < 1 year

- lack of consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• PCI
percutaneous coronary intervention

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiac mortality rate incidence of cardiac death 4-year follow-up No
Secondary major adverse cardiac event rate incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization) 4-year follow-up No
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